A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• Non-hematologic malignancy that has progressed or no standard therapy is known

• Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

• No more than 3 prior chemotherapy regimens in advanced/metastatic setting

• Absolute neutrophil count >=1,500/mm3 and platelets >=100,000/mm3

• Bilirubin <=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase <=2.5 x ULN

• Serum creatinine <=1.5 x ULN

• Men and women >=18 years

• Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study

Exclusion Criteria:

• WOCBP and men not using adequate method of birth control

• WOCBP who are pregnant or breastfeeding

• Prior radiation >=25% of bone marrow containing skeleton

• Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder

• Neuropathy

• Active brain metastases

• Inability to swallow capsules

• History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube

• Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy